Efficacy and Dose Ranging Study of Seroguard

Adhesion Clinical Trial

Official title:

Phase II Multi-center Randomized Double-blind Placebo-controlled Efficacy and Dose Ranging Trial of the Drug Product Seroguard, Solution (JSC Pharmasyntez, Russia) Used for the Prevention of Pelvic Adhesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03660787
• Other study ID #: SG-2/1215
• Status: Completed
• Phase: Phase 2
• Start date: May 4, 2017
• Est. completion date: January 23, 2018

Study information

• Verified date: June 2019
• Source: Pharmasyntez
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial was a multi-center, double-blind, randomized, parallel group, placebo-controlled, phase II study in adult hospitalized female patients with the confirmed diagnosis of pelvic adhesive disease in Study centres in Russia.

Description:

In order to evaluate efficacy and safety of Seroguard, solution for IP administration, a study design meeting the set objectives was selected: prospective, multi-center, double-blind, randomized, parallel group, placebo-controlled study.

Given the fact that comparison with placebo is considered the best way to prove efficacy and safety of a drug and that currently there are no drugs with a similar mechanism of action at the pharmaceutical product market, a placebo-controlled, parallel group study design was selected.

A randomized, parallel group study design was chosen in order to ensure minimization of a selection bias.

Subjects were randomized into four groups (two groups of the test drug and two placebo groups corresponding to the two doses) to enable a comparison of Seroguard administration at two doses.

A double-blind study design was selected in order to ensure minimization of an outcome evaluation bias.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: January 23, 2018
• Est. primary completion date: January 23, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Female patients aged from 18 to 45 years with the confirmed diagnosis of pelvic adhesions having indications for surgery (laparoscopic adhesiolysis).

2. Voluntarily and personally signed and dated Form of Informed Consent.

3. Female patients with pelvic adhesions confirmed by gynecological and ultrasound examination.

Exclusion Criteria:

1. Female patients having contraindications to surgical treatment (including acute or exacerbated chronical adnexal inflammation);

2. Body mass index of 30.0 kg/m2 and more;

3. Known hypersensitivity to the test drug components (Seroguard);

4. Pregnancy, breastfeeding or planning a pregnancy during the clinical trial;

5. Refusal to use effective contraception methods throughout the study;

6. Positive HIV, RW, HBV or HCV test result;

7. Alcohol abuse, drug addiction, and toxicomania (except smoking);

8. American Society of Anesthesiologists physical status category III and more (ASA);

9. Purulent process in the abdominal cavity;

10. Disseminated endometriosis;

11. WBC count more than 10*109/L at the complete blood count;

12. Need of using any drugs during the surgery other than 0.02% chlorhexidine aqueous solution throughout the surgery, as well as the test drug or the placebo (0.9% sodium chloride) administered intraperitoneally in the end of surgery.

13. Concomitant diseases that may require conversion of the surgical intervention by other indications;

14. Type I or II diabetes mellitus;

15. Deep vein thrombosis and/or PATE at the screening or in the medical history;

16. Renal impairment (glomerular filtration rate less than 60 mL/min/1.73 m2 assessed by the CKD-EPI equation);

17. Liver disorders defined as more than 2-fold rise of the upper limit of normal of one of the following enzymes: ALT, AST, GGTP, AP, or more than 2-fold total bilirubin increase;

18. Myocardial infarction within 6 months before screening;

19. Any concomitant diseases accompanied by heart failure;

20. Clinically significant ECG changes (as to the investigator's opinion);

21. Any concomitant diseases accompanied by respiratory failure;

22. Any oncological disease within 3 years before enrollment into the study;

23. Systemic inflammatory diseases;

24. Diseases associated with chronic hemorrhages;

25. Blood diseases (anemias of any origin, hemoglobinopathies, inherited and acquired coagulopathies, hemostasis disorders, thrombocytopenias, and thrombocytopathias, any hemoblastoses);

26. Any other disease that, in the investigator's opinion, may affect study results or present an additional threat to well-being of a patient after administration of the study drug;

27. Use of anticoagulants, antiaggregants (except for acetylsalicylic acid at the dose of less than 325 mg/day) at the moment of inclusion into the study or planning to do so during the study;

28. Use of drugs with pronounced hemato-, hepato-, or nephrotoxic action, drugs of biological origin;

29. Need to administer cytostatics, systemic glucocorticosteroids, and other immunosuppressive agents during the patient's participation in the study.

30. Participation in any other clinical trial within 30 days before screening;

31. Contraindications to MRI (presence of implants or implanted electronic devices);

32. Impossibility or inability to comply with the requirements of the protocol, including for physical, psychic or social reasons, in the investigator's opinion.

Related Conditions & MeSH terms

• Adhesion
• Tissue Adhesions

Intervention

Drug:
• Seroguard
Seroguard 0.41 g/L solution
• Placebo
Saline

Locations

Country	Name	City	State
Russian Federation	State Funded Health Care Institution "Bryansk Municipal Hospital No 1	Bryansk	The Bryansk Region
Russian Federation	State Educational Government-Financed Institution of Higher Professional Education "Kazan State Medical University" of the Ministry of Health of the Russian at the clinical site of Kazan Maternity Hospital No. 3 named after V.S. Gruzdev	Kazan	Republic Of Tatarstan
Russian Federation	Federal State Educational Government-Financed Institution of Higher Education "Kemerovo State Medical University" of the Ministry of Healthcare of the Russian Federation at the clinical site of Kemerovo Oblast Publicly Funded Healthcare Institution "L.A.	Kemerovo	The Kemerovo Region
Russian Federation	Krai Government-Owned State Funded Healthcare Institution "Krai Clinical Hospital"	Krasnoyarsk	Krasnoyarsk Krai
Russian Federation	State Educational Government-Financed Institution of Higher Professional Education "Krasnoyarsk State Medical University named after Prof. V.F. Voino-Yasenetsky" of the Ministry of Healthcare of the Russian Federation at the clinical site Publicly Funded	Krasnoyarsk	Krasnoyarsk Krai
Russian Federation	Federal State Institution "V.I. Kulakov Research Center for Obstetrics, Gynecology, and Perinatology" of the Ministry of Healthcare and Social Development of the Russian Federation.	Moscow	Moscow Region
Russian Federation	Moscow Oblast State Funded Healthcare Institution "Moscow Oblast Research Institute of Obstetrics and Gynecology"	Moscow	The Moscow Region
Russian Federation	State Funded Healthcare Institution of Moscow of City Health Department "Moscow Municipal Clinical Hospital No 31"	Moscow	The Moscow Region
Russian Federation	State Funded Healthcare Institution of Moscow of City Health Department "V.M. Buyanov Municipal Clinical Hospital"	Moscow	Moscow Region
Russian Federation	State Educational Government-Financed Institution of Higher Professional Education "Rostov State Medical University" of the Ministry of Healthcare of the Russian Federation at the clinical site of Obstetrics and Pediatrics Research Institute	Rostov-on-Don	The Rostov Region
Russian Federation	Federal State Educational Government-Financed Institution of Higher Education "I.P. Pavlov Ryazan State Medical University" of the Ministry of Healthcare of the Russian Federation at the clinical site of State Funded Healthcare Institution "Municipal Clin	Ryazan'	The Ryazan Region
Russian Federation	Federal State Funded Healthcare Institution "L.G. Sokolov Federal Biomedical Agency Clinical Hospital No 122".	Saint Petersburg	The Leningrad Region
Russian Federation	Federal State Funded Scientific Institution "Research Institute of Obstetrics, Gynecology and Reproductology named after D.O. Ott" of the Ministry of Healthcare of the Russian Federation	Saint Petersburg	The Leningrad Region
Russian Federation	Federal State Funded Healthcare Institution "Ural Research Institute of Maternal and Infant Care" of the Ministry of Healthcare of the Russian Federation	Yekaterinburg	The Sverdlovsk Region

Sponsors (2)

Lead Sponsor	Collaborator
Pharmasyntez	Cromos Pharma, LLC

Country where clinical trial is conducted

Russian Federation, 

References & Publications (35)

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* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Reduction of Adhesions Number by 3 or More	The number of adhesions according to the first MRI data was compared to the number according to the data of second MRI	30±4 days after surgical intervention
Secondary	Change in Thickness of Pelvic Adhesions	The change from baseline was defined. It was evaluated by comparing baseline MRI data and repeated MRI data. Results were estimated according to scale from 0 to 3 where 0 - no adhesions, 1 - thin (filmy or filiform), 2 - marked, 3 - marked with an impaired passage through organs involved.	30±4 days after surgery
Secondary	Number of Participants With Detection of Pelvic Organs Limited Mobility	The frequency was estimated based on transvaginal ultrasound results	30±4 days after surgery
Secondary	Number of Participants With Detection of Hyperechoic Linear Lesions Post Surgery	The frequency was estimated based on transvaginal ultrasound results	30±4 days after surgery
Secondary	Change in Number of Participants in Detecting Pelvic Organs Limited Mobility	Absolute change of count of participants was measured with detecting pelvic organs limited mobility from the baseline	30±4 days after surgery
Secondary	Change Number of Participants in Detecting Hyperechoic Linear Lesions	Frequency of detecting after repeated transvaginal ultrasound results was compared to baseline indications (4 or more)	30±4 days after surgery
Secondary	Number of Participants With Detection of no Ultrasound Signs of Pelvic Adhesive Disease Post Surgery	No limited mobility of pelvic organs and no hyperechoic linear lesions should be shown	30±4 days after surgery